Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy

NCT ID: NCT02563665

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

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All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.

Detailed Description

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Conditions

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CKD With Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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advanced chronic kidney disease

Subjects on dialysis with GFR (Glomerular Filtration Rate) \> 30

No interventions assigned to this group

Renal replacement therapy.

Subjects who are not on dialysis with GFR (Glomerular Filtration Rate) \< 15

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria

1. Age less than 18 years
2. Confirmed pregnancy
3. HCV-HIV Co infection
4. HBV-HCV co infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Suman Lata Nayak, DM

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-HCKD/001/SOFO/2015

Identifier Type: -

Identifier Source: org_study_id

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